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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 01:12

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Active filter:EMDN:W01021308

99 device results listed.

Page 5 / 5

Troponin I Ultra Rapid Test Kit

A02103002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861684204
Basic UDI-DI: B-06973861684204
Reference: A02103002
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:43

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598231913
Basic UDI-DI: B-06942598231913
Reference: FI-CRP-402
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-reactive Protein Kit（Particle-enhanced Immunoturbidimetric Assay Method）

-

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904031682
Basic UDI-DI: 694490400043HS-CRP*****PP
Reference: 105-001943-00
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-reactive Protein Kit（Particle-enhanced Immunoturbidimetric Assay Method）

-

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904031699
Basic UDI-DI: 694490400043HS-CRP*****PP
Reference: 105-001944-00
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-reactive Protein Kit（Particle-enhanced Immunoturbidimetric Assay Method）

-

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904031705
Basic UDI-DI: 694490400043HS-CRP*****PP
Reference: 105-002201-00
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-reactive Protein Kit（Particle-enhanced Immunoturbidimetric Assay Method）

-

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904031712
Basic UDI-DI: 694490400043HS-CRP*****PP
Reference: 105-002202-00
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-reactive Protein Kit（Particle-enhanced Immunoturbidimetric Assay Method）

-

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904031729
Basic UDI-DI: 694490400043HS-CRP*****PP
Reference: 105-002203-00
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

HS-CRP Calibrator

-

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037837
Basic UDI-DI: 694490400043HS-CRP*****PP
Reference: 105-003685-00
EMDN: W01021308
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

HS-CRP STAT (eCLIA)

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063904
Basic UDI-DI: 69703416803205095JY
Reference: 0320511402
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

HS-CRP STAT (eCLIA)

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063911
Basic UDI-DI: 69703416803205095JY
Reference: 0320511403
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

HS-CRP STAT (eCLIA)

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063928
Basic UDI-DI: 69703416803205095JY
Reference: 0320511404
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ hsCRP

ichroma™ hsCRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043455
Basic UDI-DI: 880613300063BT
Reference: CFPC-6
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay)

hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792621
Basic UDI-DI: 695441470202GS
Reference: IF5003
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay )

hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay )

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702026
Basic UDI-DI: B-06954414702026
Reference: /
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitive C-Reactive Protein (hs-CRP) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334804468
Basic UDI-DI: B-06950334804468
Reference: 52026010
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967223313
Basic UDI-DI: B-06941967223313
Reference: 01.09.05.00.EC.01
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reactive Protein Kit (Latex-Enhanced Immunoturbidimetric Method)

-

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751901
Basic UDI-DI: B-06936595751901
Reference: MJ021Y
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reaction Protein（hs-CRP）Kit (Latex Particle-Enhanced Immunonephelometry Method）

-

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415996550
Basic UDI-DI: 69449040AB70000163X
Reference: 105-019042-00
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289809382
Basic UDI-DI: B-06933289809382
Reference: W240
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 11:05

Manufacturer products Authorised representative products Authorised representative actors View details